Arthropathy of KneeNCT05381818
Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery
A study testing Daily Inspiratory Muscle Training (dIMT) and Acute Inspiratory Muscle Training (aIMT) in people with Arthropathy of Knee and Arthropathy of Hip, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arthropathy of Knee, Arthropathy of Hip, Lower Extremity Fracture
- What is being tested?
- Daily Inspiratory Muscle Training (dIMT) and Acute Inspiratory Muscle Training (aIMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- History of current or previous tobacco use (including vaping containing nicotine products)
- One or more risk factors for post operative pulmonary complications including history of current or previous tobacco use, a clinically diagnosed lung disease, shortness of breath with minimal exertion, FEV1 or FVC less than 80% than predicted or respiratory muscles strength below lower limit of normal for age and sex.
- History of smoking related lung disease
- Projected surgical time > 30 minutes
- Ability to follow instructions to complete IMT exercises
- Ability to communicate adverse effects such as pain or fatigue or the need for assistance
Who cannot join
- American Society of Anesthesiologists physical status classification of 4 or greater .
- Recent history of acute pneumonia or lower respiratory infection in the previous two weeks requiring acute corticosteroid or antibiotic medication,
- Preoperative dependence on continuous supplemental oxygen dependence.
- Preoperative dependence on positive pressure breathing support while awake and upright (night time CPAP permitted),
- Diagnosis of a neurologic condition (i.e. MS, ALS, Parkinson's, stroke),
- Participating in a pulmonary rehabilitation program
- Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1<50% predicted.
- Patients with an infectious disease requiring isolation (i.e. COVID-19).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Jacksonville, Florida, 32209
Maribel Ciampitti, MS, 904-244-4690, maribel.ciampitti@jax.ufl.edu
Jennifer Bowman, Jennifer.Bowman@jax.ufl.edu
About this study
Official title: Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery
The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.
Read the detailed description
Preoperative inspiratory muscle training (IMT) has been shown to reduce post operative complications (PPC's) following prolonged cardiac surgeries, but its potential benefits have not been investigated in shorter surgeries with expected brief post-operative hospitalizations. We intend to address this unmet need by investigating preoperative IMT, an evidence-based rehab strategy to optimize lung function, prior to total joint arthroplasty surgery. The fundamental hypothesis guiding this proposal is that preoperative IMT will attenuate post-operative declines in breathing function and offset PPCs. To test this hypothesis, we will conduct a single center, randomized, prospective pilot study. Adults scheduled for total joint arthroplasty or lower extremity orthopedic surgery will be randomized to either complete daily IMT in advance of surgery (dIMT), a single acute IMT session immediately before surgery (aIMT), or usual surgical standard of care (SOC). Inspiratory muscle strength and pulmonary function will be evaluated upon enrollment ~4 weeks in advance of surgery and in pre-operative holding, and post-operative declines will be investigated through the first 24 hours (Aim 1). Further, we will investigate the effect of training assignment on post-operative clinical outcomes (Aim 2).
- Being tested
- Daily Inspiratory Muscle Training (dIMT), Acute Inspiratory Muscle Training (aIMT), Standard of Care (SOC)
- Keywords
- Inspiratory muscle training, Pulmonary complications, Total joint replacement
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Inspiratory Muscle Training (dIMT)Behavioural
Daily IMT training sessions for 2-4 weeks prior to surgery
Acute Inspiratory Muscle Training (aIMT)Behavioural
A single session of IMT provided within 30 minutes prior to anesthesia induction.
Standard of Care (SOC)Other
Standard of care only pre and post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Daily IMT (dIMT) | Experimental | IMT (inspiratory muscle training) is a treatment strategy aimed to strengthen the muscles of inspiration, the diaphragm and external intercostals, by increasing their force-generating capacity. Participants in the dIMT (daily IMT) will complete daily inspiratory training exercises 2-4 weeks prior to surgery. A pressure threshold training device containing an adjustable-tension spring to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths daily at a pressure 70% of MIP and will rest 1 minute between sets. They will be asked to keep a log to track their sessions to evaluate compliance with the exercise regimen. Receives: Behavioral: Daily Inspiratory Muscle Training (dIMT) |
| Acute IMT (aIMT) | Active comparator | Patients in the aIMT (acute IMT) experimental group will complete a single session of IMT guided by a physical therapist within 30 minutes of anesthesia induction in addition to standard of care. The adjustable pressure threshold training device to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest 1 minute between sets. The training intensity will be set at 70% of MIP. Receives: Behavioral: Acute Inspiratory Muscle Training (aIMT) |
| Standard of Care (SOC) | Active comparator | The SOC group will receive the usual surgical standard of care only. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (MIP)
Measure of strength of inspiratory muscles.
Measured: 24-hours post-op.
Forced vital capacity (FVC)
The volume of air that can be forcefully exhaled after a full inhalation.
Measured: 24-hours postoperative changes
Secondary outcomes (1)
Post operative pulmonary complications
Incidence of post-operative pulmonary complications
Measured: 10 days Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jul 2022
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Barbara Smith, PhD, Principal investigator, University of Florida, College of Public Health and Health Professions - Gainesville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381818
- Sponsor's protocol ID
- IRB202102681
- Other IDs
- R21AG083667
- Status last verified
- Aug 2025
- First submitted
- 16 May 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith BK, Shaner J, Gitlin A, Meier W, Wang S, Ciampitti M, Elias-Grajeda T, Khan U, Washington J, Freidl M, Braunecker S. Inspiratory Muscle Training Before Total Joint Arthroplasty to Improve Postoperative Outcomes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Sep 11;15:e103290. doi: 10.2196/103290.
PubMed 42726784
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery
- ClinicalTrials.gov ID
- NCT05381818
- Acronym / sponsor ID
- IRB202102681
- Keywords
- Inspiratory muscle training, Pulmonary complications, Total joint replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.
Detailed description
Preoperative inspiratory muscle training (IMT) has been shown to reduce post operative complications (PPC's) following prolonged cardiac surgeries, but its potential benefits have not been investigated in shorter surgeries with expected brief post-operative hospitalizations. We intend to address this unmet need by investigating preoperative IMT, an evidence-based rehab strategy to optimize lung function, prior to total joint arthroplasty surgery. The fundamental hypothesis guiding this proposal is that preoperative IMT will attenuate post-operative declines in breathing function and offset PPCs. To test this hypothesis, we will conduct a single center, randomized, prospective pilot study. Adults scheduled for total joint arthroplasty or lower extremity orthopedic surgery will be randomized to either complete daily IMT in advance of surgery (dIMT), a single acute IMT session immediately before surgery (aIMT), or usual surgical standard of care (SOC). Inspiratory muscle strength and pulmonary function will be evaluated upon enrollment ~4 weeks in advance of surgery and in pre-operative holding, and post-operative declines will be investigated through the first 24 hours (Aim 1). Further, we will investigate the effect of training assignment on post-operative clinical outcomes (Aim 2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daily IMT (dIMT) | Experimental | Behavioral: Daily Inspiratory Muscle Training (dIMT)IMT (inspiratory muscle training) is a treatment strategy aimed to strengthen the muscles of inspiration, the diaphragm and external intercostals, by increasing their force-generating capacity. Participants in the dIMT (daily IMT) will complete daily inspiratory training exercises 2-4 weeks prior to surgery. A pressure threshold training device containing an adjustable-tension spring to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths daily at a pressure 70% of MIP and will rest 1 minute between sets. They will be asked to keep a log to track their sessions to evaluate compliance with the exercise regimen. |
| Acute IMT (aIMT) | Active comparator | Behavioral: Acute Inspiratory Muscle Training (aIMT)Patients in the aIMT (acute IMT) experimental group will complete a single session of IMT guided by a physical therapist within 30 minutes of anesthesia induction in addition to standard of care. The adjustable pressure threshold training device to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest 1 minute between sets. The training intensity will be set at 70% of MIP. |
| Standard of Care (SOC) | Active comparator | Other: Standard of Care (SOC)The SOC group will receive the usual surgical standard of care only. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 or older
- History of current or previous tobacco use (including vaping containing nicotine products)
- One or more risk factors for post operative pulmonary complications including history of current or previous tobacco use, a clinically diagnosed lung disease, shortness of breath with minimal exertion, FEV1 or FVC less than 80% than predicted or respiratory muscles strength below lower limit of normal for age and sex.
- History of smoking related lung disease
- Projected surgical time > 30 minutes
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists physical status classification of 4 or greater .
- Recent history of acute pneumonia or lower respiratory infection in the previous two weeks requiring acute corticosteroid or antibiotic medication,
- Preoperative dependence on continuous supplemental oxygen dependence.
- Preoperative dependence on positive pressure breathing support while awake and upright (night time CPAP permitted),
- Diagnosis of a neurologic condition (i.e. MS, ALS, Parkinson's, stroke),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Inspiratory Muscle Training (dIMT)Daily IMT training sessions for 2-4 weeks prior to surgery | Behavioural | Daily IMT (dIMT) |
| Acute Inspiratory Muscle Training (aIMT)A single session of IMT provided within 30 minutes prior to anesthesia induction. | Behavioural | Acute IMT (aIMT) |
| Standard of Care (SOC)Standard of care only pre and post-operatively. | Other | Standard of Care (SOC) |
Primary outcome
Maximal Inspiratory Pressure (MIP)
Time frame: 24-hours post-op.
Measure of strength of inspiratory muscles.
Forced vital capacity (FVC)
Time frame: 24-hours postoperative changes
The volume of air that can be forcefully exhaled after a full inhalation.
1 secondary outcome
Post operative pulmonary complications
Time frame: 10 days Post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 42726784Smith BK, Shaner J, Gitlin A, Meier W, Wang S, Ciampitti M, Elias-Grajeda T, Khan U, Washington J, Freidl M, Braunecker S. Inspiratory Muscle Training Before Total Joint Arthroplasty to Improve Postoperative Outcomes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Sep 11;15:e103290. doi: 10.2196/103290.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Smith, PhD principal investigator
University of Florida, College of Public Health and Health Professions - Gainesville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Inspiratory Muscle Training (dIMT) and Acute Inspiratory Muscle Training (aIMT) in people with Arthropathy of Knee and Arthropathy of Hip, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maribel Z Ciampitti (904-891-6403, maribel.ciampitti@jax.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (MIP) (time frame: 24-hours post-op.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05381818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.